- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06965712
- Original Trial
Use of Point-of-Care Ultrasound (POCUS) to Reduce Hospital Length of Stay in Patients With Heart Failure ( POCUSHF ) (POCUSHF)
Use of Point-of-Care Ultrasound (POCUS) to Guide Fluid Management and Reduce Hospital Length of Stay in Patients With Decompensated Heart Failure
Study Overview
Status
Intervention / Treatment
Detailed Description
This clinical trial aims to determine whether the use of bedside ultrasound (also called Point-of-Care Ultrasound, or POCUS) can improve the management of patients hospitalized with decompensated heart failure. Traditional methods for assessing heart failure patients rely heavily on physical examination and imaging tests such as chest X-rays, which may not always accurately reflect a patient's volume status. POCUS provides real-time information at the bedside, allowing clinicians to assess lung congestion and venous volume status quickly and non-invasively.
Participants in this study will be randomly assigned to one of two groups. The intervention group will undergo POCUS assessments of the lungs and inferior vena cava (IVC) twice during their hospitalization: once within 24 hours of admission and once before discharge. The control group will receive standard clinical care without ultrasound guidance. All participants' clinical information, including length of hospital stay, treatments administered, and 30-day readmission status, will be collected and analyzed.
The primary objective is to determine whether POCUS-guided management leads to a reduction in hospital length of stay. Secondary objectives include evaluating whether ultrasound guidance affects 30-day readmission rates and diuretic therapy adjustments. The study is expected to enroll approximately 66 patients.
This research may help establish whether POCUS can be incorporated into standard care practices for hospitalized heart failure patients, potentially leading to better outcomes and more efficient use of hospital resources.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: GUILLERMO IZQUIERDO PRETEL, MD
- Phone Number: 13058128099
- Email: gizquier@fiu.edu
Study Contact Backup
- Name: FIU TEAM F
- Phone Number: 3055101801
- Email: sacramento1624@gmail.com
Study Locations
-
-
Florida
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Miami, Florida, United States, 33136
- Recruiting
- Jackson Memorial Hospital
-
Contact:
- GUILLERMO IZQUIERDO-PRETEL, MD
- Phone Number: 305-812-8099
- Email: gizquier@fiu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Adults aged 18 years and older.
Hospitalized with a primary diagnosis of decompensated heart failure (left, right, or biventricular).
Evidence of volume overload or congestion based on Framingham criteria, clinical examination, elevated proBNP (>1000 pg/mL), or chest X-ray showing pulmonary edema.
Ability to undergo bedside ultrasound evaluation (POCUS) as clinically feasible.
Able to provide informed consent.
Exclusion Criteria:
Age under 18 years.
Pregnant or breastfeeding women.
Terminal illness with life expectancy < 30 days.
Inability to obtain ultrasound images due to body habitus or other technical reasons.
Enrollment in another interventional clinical trial that could interfere with the outcomes of this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: POCUS-Guided Evaluation Group
Participants in this group will receive bedside Point-of-Care Ultrasound (POCUS) evaluations of the lungs and inferior vena cava (IVC) twice during hospitalization, once within 24 hours of admission and once prior to discharge.
Ultrasound findings will be used to guide fluid management decisions.
|
Participants assigned to this group will receive Point-of-Care Ultrasound (POCUS) evaluations of the lungs and inferior vena cava (IVC) during their hospital stay.
The ultrasound will be performed twice: once within 24 hours of hospital admission and once prior to hospital discharge.
The POCUS findings will be used to guide clinical management decisions regarding fluid status and decongestion therapy in patients with decompensated heart failure.
The procedure is non-invasive, radiation-free, and performed at the bedside.
|
|
No Intervention: Standard Clinical Evaluation Group
Participants in this group will receive standard clinical care without bedside ultrasound guidance.
Clinical evaluation and management will be based on physical examination, chest X-rays, laboratory results, and physician judgment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital Length of Stay (LOS)
Time Frame: From the date of hospital admission to the date of discharge order, assessed up to 30 days.
|
Hospital Length of Stay (LOS) will be measured as the number of days from hospital admission to discharge decision.
LOS will be compared between the POCUS-guided group and the standard care group.
|
From the date of hospital admission to the date of discharge order, assessed up to 30 days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30-Day Hospital Readmission Rate
Time Frame: Within 30 days after hospital discharge
|
The proportion of patients readmitted to any hospital for any cause within 30 days after discharge will be recorded and compared between the POCUS-guided group and the standard care group.
|
Within 30 days after hospital discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: GUILLERMO IZQUIERDO PRETEL, MD, Florida International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-0179
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
I am running a single-center investigator-initiated study. I am not creating a formal public repository for the individual patient data.
At this stage, I am focused on analyzing your results internally (not distributing patient-level data to outside researchers).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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